GNH USA

Europe — EMA

Mepact

GNH USA supplies Mepact (Mifamurtide), an immunostimulant antineoplastic for high‑grade, non‑metastatic osteosarcoma after surgery.

Mifamurtide

Request sourcing

1
Pack/s

What is Mifamurtide?

Mifamurtide, the active ingredient in Mepact, is an immunostimulant (antineoplastic) presented as a 1 mg per vial lyophilized powder for intravenous infusion use. It is indicated for high‑grade, non‑metastatic osteosarcoma after complete surgical resection, where it is administered as part of adjuvant therapy to improve disease‑free survival.

GNH USA supplies Mepact as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide, providing reliable sourcing for clinical oncology programs, including academic and private institutions, and supporting regulatory compliance for cross‑border distribution.

What is Mifamurtide used for?

Mepact (mifamurtide) is used as an immunotherapy for osteosarcoma, acting through innate immune activation.

- High‑grade, non‑metastatic osteosarcoma (adjuvant setting): improves disease‑free survival after complete surgical resection.

What are the side effects of Mifamurtide?

Mepact may cause a range of adverse reactions during and after infusion.

Common Side Effects: - Fever: transient elevation of body temperature during infusion. - Chills: shaking or shivering episodes. - Nausea: mild to moderate upset stomach. - Vomiting: occasional emesis post‑infusion. - Fatigue: generalized tiredness. - Hypotension: temporary drop in blood pressure.

Serious or Rare Side Effects: - Anaphylaxis: severe allergic reaction requiring immediate medical attention. - Hepatotoxicity: elevated liver enzymes indicating liver stress. - Cytokine release syndrome: systemic inflammatory response. - Severe hypotension requiring vasopressors. - Acute respiratory distress: difficulty breathing during infusion.

What precautions apply to Mifamurtide?

Before initiating therapy, clinicians should evaluate patient suitability and monitor for potential complications.

- Infusion reactions: monitor vital signs during and after administration. - Hepatic function: assess liver enzymes prior to each cycle. - Infection risk: defer treatment in patients with active severe infections. - Pediatric use: adjust monitoring as children may experience heightened cytokine responses. - Pregnancy and lactation: safety unknown; avoid use unless benefits outweigh risks. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Mifamurtide interact with?

Mepact may interact with other agents that affect immune function or hemodynamics.

Major Interactions (Avoid): - Live vaccines: concurrent administration may cause uncontrolled immune activation. - Known hypersensitivity to excipients: avoid to prevent severe allergic reactions. - Other immunostimulants: may amplify cytokine release syndrome.

Moderate Interactions (Monitor Closely): - Anticoagulants: monitor coagulation parameters due to potential platelet activation. - Nephrotoxic drugs: assess renal function as cytokine surge can affect kidney perfusion. - Concurrent antineoplastic agents: watch for overlapping toxicities, especially hepatic and hematologic effects.

Frequently asked questions

What is Mepact used for?+
Mepact contains the immunostimulant mifamurtide and is approved for the adjuvant treatment of high‑grade, non‑metastatic osteosarcoma after complete surgical resection. It is given intravenously to help reduce the risk of disease recurrence.
How does Mifamurtide work?+
Mifamurtide activates the intracellular NOD2 receptor in macrophages and dendritic cells, leading to the release of cytokines that boost innate immune activity. This enhanced immune response promotes the recognition and destruction of residual osteosarcoma cells following surgery.
What is the usual dose of Mepact?+
The specific dose and schedule of Mepact are determined by the prescribing oncologist based on the patient’s weight, clinical status, and treatment protocol. The product is supplied as a 1 mg lyophilized vial that is reconstituted for intravenous infusion.
Is Mepact safe during pregnancy or breastfeeding?+
Safety of mifamurtide in pregnancy and lactation has not been established. It is generally avoided unless the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision should be made by a qualified healthcare professional.
How do I order Mepact from GNH USA?+
To request Mepact, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and necessary import documentation.
How does Mepact compare with other osteosarcoma therapies?+
Mepact is unique in that it is an immunostimulant rather than a conventional cytotoxic chemotherapy. It is used alongside standard multi‑agent regimens and specifically targets the innate immune system, whereas other agents such as methotrexate, doxorubicin or cisplatin act directly on tumor cell proliferation.
What are the storage and handling requirements for Mepact?+
Mepact vials must be stored refrigerated at 2‑8 °C, protected from light, and should never be frozen or shaken. Prior to use, the lyophilized powder is reconstituted with the appropriate diluent under aseptic conditions.
How is Mepact administered?+
Mepact is given as an intravenous infusion. After reconstitution, the solution is infused over a specified period, typically 30‑60 minutes, under close clinical monitoring for infusion‑related reactions.
What are the most serious risks associated with Mepact?+
Serious adverse events include anaphylaxis, severe hypotension, cytokine release syndrome, and significant liver enzyme elevations. Prompt recognition and management of these reactions are essential, and patients should be observed closely during and after the infusion.
Who should not receive Mepact?+
Mepact is contraindicated in patients with known hypersensitivity to mifamurtide or any excipients, those receiving live vaccines, and individuals with active severe infections. Caution is also advised for patients with uncontrolled cardiovascular disease or severe hepatic impairment.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Mifamurtide
Route
Intravenous Use
Manufacturer
Takeda France Sas
Origin
EU

Related products